Flush enhancing male luer tip design for syringes and any luer connector

ABSTRACT

A luer connection device is disclosed having a housing including a side wall having an inside surface defining a lumen with a central axis, an proximal end, and a distal end including a male luer tip within the lumen having a central flow diverter extending outwardly from the central axis to direct a fluid to a circumferential dead space distal to the male luer tip. A luer connection device is also disclosed having a flow expansion channel disposed in the lumen tapering outward from the wall of tubular housing and partially extending along a longitudinal axis from the tip opening toward the base opening for increasing mixing and flow through a circumferential dead space in the fluid path distal to the male luer tip.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application is a divisional of U.S. patent application Ser. No.16/397,268, filed on Apr. 29, 2019, now U.S. Pat. No. 11,779,745 issuedon Oct. 10, 2023, which is a divisional of U.S. patent application Ser.No. 15/388,476, filed on Dec. 22, 2016, issued as U.S. Pat. No.10,272,237 on Apr. 30, 2019, which is a divisional of U.S. patentapplication Ser. No. 13/476,357 filed on May 21, 2012, now U.S. Pat. No.9,616,214 issued on Apr. 11, 2017, the entire disclosure of which ishereby incorporated by reference herein.

TECHNICAL FIELD

An aspect of the invention relates generally to a luer connectiondevice, and more particularly to a luer connection device a housingincluding a side wall having an inside surface defining a lumen with acentral axis, a proximal end, and a distal end including a male luer tipwithin the lumen having a central flow diverter extending outwardly fromthe central axis to direct a fluid to a circumferential dead spacedistal to the male luer tip. Another aspect of the invention relates aluer connection device having a flow expansion channel disposed in thelumen tapering outward from the wall of tubular housing and partiallyextending along a longitudinal axis from the tip opening toward the baseopening for increasing mixing and flow through a circumferential deadspace in the fluid path distal to the male luer tip. Yet another aspectof the invention relates a luer connection device having both a centralflow diverter and a flow expansion channel disposed within the lumen.

BACKGROUND

Vascular Access Devices (VADs) are commonly used therapeutic devices andinclude intravenous catheters, syringes, extension sets, stop cocks,tubing, high pressure extension tubing, and needleless access devices.The operation of VADs is often compromised or completely prevented bythe occurrence of thrombus formation. Thrombosis is the development of ablood clot within a vessel and/or vascular access device. If notproperly maintained, VADs can become occluded. To ensure VADs are usedproperly and do not become occluded, standards of practice have beendeveloped. These standards include a cleaning procedure, which iscommonly referred to as a flush procedure. The purpose of flushing is toclean the accumulated residue from dead-space located between male andfemale luer connections. The common flushing practice creates aturbulent flow during flushing to promote a “scrubbing” effect in thelumen and at the tip of the catheter.

The effectiveness of the flushing procedure in intravenous therapy isrelated to the risk of microbial colonization and potential CatheterRelated Bloodstream Infection (CRBSI). Standard male luer tip geometriesresult in a circumferential “dead space” in the fluid path distal to themale luer tip that is inherently difficult to flush. After standardflushing procedures, an excess amount of blood can be left in thisdifficult to flush region, thereby increasing the risk of microbialcolonization. Thus, the greater the amount of blood and residueremaining in the catheter system, the higher the risk for infection andcomplications related to infection. Clinicians can attempt to improveflushing with pulsatile techniques that may encourage mixing and betterflush results. Due to these inherent challenges, there is a need for adevice that improves the outcome of a flush procedure by removing theblood and residue build up found in the circumferential “dead space”.

SUMMARY

Embodiments of the present invention are directed to a luer connectiondevice including a housing having a side wall with an inside surfacedefining a lumen with a central axis, a proximal end, and a distal endincluding a male luer tip within the lumen having a passagewaytherethrough providing fluid communication between the proximal end andthe distal end. The male luer tip disposed within the lumen at or nearthe distal end including a central flow diverter extending outwardlyfrom the central axis to direct a fluid to a circumferential dead spacedistal to the male luer tip.

In one or more embodiments, the luer connection device may also includeat least one flow expansion channel for increasing flow and mixing afluid through a circumferential dead space in the fluid path distal tothe male luer tip. The flow expansion channel can be configured toextend in a straight taper outwardly from the central axis of the lumen.In one or more embodiments, the flow expansion channel may be configuredto extend in a rotational taper outwardly from the central axis of thelumen. The flow expansion channel can be located upstream from the flowdiverter.

The proximal end of the luer connection device can be integrallyconnected to a vascular access device. The vascular access device may bea syringe, extension set, intravenous set, stop cock, tubing, highpressure extension tubing, or needleless access device. The luerconnection device can be removably connected to a vascular accessdevice.

In one or more embodiments, the central flow path diverter comprises aplurality of vanes. In one or more embodiments, the plurality of vanesmay have a tapered leading edge and tapered tailing edge to minimizedrag and reduce resistance. The tapered leading edge may be configuredto create a smooth entrance of fluid and the tapered tailing edge isconfigured to create a sharp exit for producing turbulent fluid flowupon exiting the flow diverter.

In one or more embodiments, the plurality of vanes may be configured toextend straight outwardly from the central axis of the lumen to the sidewall. In one variation, the plurality of vanes extends outwardly fromthe central axis of the lumen in a curved configuration. At least oneedge of the plurality of vanes can have a ramped angled surface tocreate a greater angle of incidence. The central flow path diverter canbe configured in various shapes, for example, in a cross, rectangle,star, triangle, oval, spiral, twisting or helical formation.

An aspect invention pertains to a luer connection device including ahousing having a side wall with an inside surface defining a lumen, aproximal end and a distal end including a distal wall with an elongatemale luer tip extending in a distal direction therefrom having apassageway therethrough providing fluid communication between theproximal end and the distal end; and a flow expansion channel beingdisposed in the lumen tapering outward from the wall of tubular housingand partially extending along a longitudinal axis from the tip openingtoward the base opening for increasing mixing and flow through acircumferential dead space in the fluid path distal to the male luertip.

The proximal end can be integrally connected to a vascular accessdevice. The vascular access device may be a syringe, extension set,intravenous set, stop cock, tubing, high pressure extension tubing, orneedleless access device. In one or more embodiments, the syringe is apre-filled flush syringe. The luer connection device can be removablyconnected to a vascular access device.

The flow expansion channel can be configured to extend in a straighttaper outwardly from the central axis of the lumen. The flow expansionchannel may be configured to extend in a rotational taper outwardly fromthe central axis of the lumen. The flow expansion channel may beconfigured to scallop outwardly from the central axis of the lumen. Inone or more embodiments, the flow expansion channel is located at thedistal end and projects axially in a proximal direction towards theproximal end.

In one or more embodiments, the luer connection device also includes aflow diverter disposed in the lumen at or near the distal end of themale luer tip to direct the fluid flow to the periphery of a connectingfemale luer space upon application of force in the distal direction. Theflow diverter can extend beyond the distal end of the housing. The flowdiverter may be connected to the flow expansion channel. The flowexpansion channel may be located upstream from the flow diverter.

In an embodiment, the flow diverter can direct fluid flow into the flowexpansion channel. In another embodiment, the flow expansion channeldirects fluid flow into the flow diverter.

In one or more embodiments, the flow expansion channel and flow diverterare both configured to extend in a straight taper towards the centralaxis of the lumen. In another embodiment, the flow expansion channel isconfigured to extend in a rotational taper towards the central axis ofthe lumen and flow diverter is configured to extend in a straight tapertowards the central axis of the lumen. In yet another embodiment, theflow diverter is configured to extend in a rotational taper towards thecentral axis of the lumen and flow expansion channel is configured toextend in a straight taper towards the central axis of the lumen.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 shows a standard prior art luer connection device having astandard male luer tip straight central fluid path having zones of flowstagnation.

FIG. 2 is a cross-sectional view of the luer connection device having aflow diverter and flow expansion channel.

FIG. 3 is a cross-sectional view of the luer connection device havingstraight non-rotational flow expansion channels and rotational flowdiverter.

FIG. 4 is a cross-sectional of the luer connection device havingstraight non-rotational flow expanding channels.

FIG. 5 is a cross-sectional of the luer connection device havingrotational flow expansion channels.

FIG. 6 shows a front view of the luer connection device having astraight non-rotational flow expansion channels and rotational diverterhaving ramped angled edges.

FIG. 7 shows a plan view of the luer connection device having a flowdiverter and straight flow expansion channels.

FIG. 8 shows a plan view of the luer connection device having a flowdiverter and rotational flow expansion channels.

DETAILED DESCRIPTION

Before describing several exemplary embodiments of the invention, it isto be understood that the invention is not limited to the details ofconstruction or process steps set forth in the following description.The invention is capable of other embodiments and of being practiced orbeing carried out in various ways.

In this disclosure, a convention is followed wherein the distal end ofthe device is the end closest to a patient and the proximal end of thedevice is the end away from the patient and closest to a practitioner.

Many VADs have luer fittings which contain male luer tips. FIG. 1 showszones of flow stagnation, depicted as “A”, where blood-derived debriscan typically form in a standard prior art luer connection device havinga standard male luer tip straight central fluid path.

The present invention overcomes problems associated with known flushingtechniques by providing a luer connection device having a male luer tipthat effectively scrubs the blood, residue and other debris fromdeadspace located between male and female luer connections. The presentinvention provides a luer connection device having a male luer tip withinternal geometry that promotes improved flushing of any male to femaleluer connection whether it is connecting to a catheter, extension set,IV set, IV access device or any connector that includes a male luer forconnection to a female luer. The luer connection device may be a standalone component or may be integrally connected to a vascular accessdevice that requires enhanced flushing prior to being connected to thefemale luer connection and performing the flush procedure. The luerconnection device of the present invention includes a male luer tiphaving a flow diverter 80 and/or flow channels 90 in a variety of formsto improve the removal of blood in the systems for a given flush volume.The present invention may also be useful for flushing needless IV accessvalves, such as BD Q-Syte™. The luer connection device of the presentinvention can be removably attached or integrally attached to apre-filled flush syringe for improved clinical outcomes. The luerconnection device of the present invention may also be used incombination with other CRBSI risk reducing features, including,antimicrobial solutions and cleaning and protection caps, to establishan improved practice for reducing CRSI risk associated with flushing aninfusion system.

FIGS. 2-4 illustrate an exemplary luer connection device 10 according tothe present invention. Luer connection device 10 includes a housing 20having a side wall 30 with an inside surface defining a lumen 40 with acentral axis, a proximal end 50, and a distal end 60 including a maleluer tip 70 within the lumen having a passageway therethrough providingfluid communication between the proximal end 50 and the distal end 60through which fluid, e.g. flush fluid, may be ejected. The male luer tip70 disposed within the lumen at or near the distal end includes acentral flow diverter 80 extending outwardly from the central axis todirect fluid flow to a peripheral circumferential dead space locateddistal to the male luer tip.

In one or more embodiments, the luer connection device 10 may alsoinclude at least one flow expansion channel 90 for increasing mixing andflow through circumferential dead space in the fluid path distal to themale luer tip. The flow expanding channel 90 increases mixing and flowthrough the “dead” space, thereby significantly improving the removal ofthe blood, medicine and/or other fluids and provide superior flushing.In the embodiment shown, flow expansion channel 90 is disposed on theinterior surface of the housing lumen 40 and can be round, square,triangular, or a combination thereof, or any other suitable shape.Specifically, the flow expansion channel 90 is shown as a structure thatprojects outward from the side wall 30 of the housing lumen 40 andreduces the cross-sectional width of the lumen 40. The cross-sectionalwidth of the interior surface of the lumen at the flow expansion channelis less than the cross-sectional width of the lumen at the remainingportions. It will be understood that the flow expansion channel 90 maybe disposed at other locations along the interior surface of the sidewall 30. In another variant, the flow expansion channel 90 may include aplurality of outwardly extending projections disposed along the axiallength of the housing 20 and may be disposed at pre-defined intervalsalong the axial length. The flow expansion channels also extendlongitudinally along the length of the lumen and may be disposed atintervals along the length of the lumen. In one or more embodiments, theflow expansion channels may be tapered. In one or more embodiments, theflow expansion channel 90 is configured to extend in a straight taperoutwardly from the lumen 40 towards the central axis of the lumen. Inone or more embodiments, the flow expansion channel 90 may be configuredto extend in a rotational taper outwardly from the central axis of thelumen. In one or more embodiments, the flow expansion channel 90 islocated upstream from the flow diverter 80.

It will be appreciated that the flow diverter 80 and/or flow expansionchannel 90 is located within the interior surface of the lumen 40 forcesfluid to peripheral space formed between the male and female luerconnections. The central flow path diverter, alone or in combinationswith the flow expansion channels, significantly improves the flushingand removal of fluid downstream from the luer tip by forcing the fluidto the periphery or the female luer space. Thus, the present inventionimproves flow based on flow expansion, disruptions of dead spacecreating features, and flow diversion outward.

In one or more embodiments, the proximal end 50 of the luer connectiondevice 10 is integrally connected to a vascular access device. Thevascular access device may be a syringe, extension set, intravenous set,stop cock, tubing, high pressure extension tubing, or needleless accessdevice. In one or more embodiments, the luer connection device isremovably connected to a vascular access device.

In one or more embodiments, the central flow path diverter comprises aplurality of vanes. As used herein, a vane can include any number ofknown internal dividers capable of manipulating the path of a liquid.Internal dividers may include louvers or tapered leading and tailingedges. The plurality of vaines create turbulence in the flow of flushingfluid to reduce the dead space which might otherwise form on theperipheral surface of the wall portion located between the male luer andfemale luer connection. In one or more embodiments of the presentinvention, the plurality of vanes may have a tapered leading edge andtapered tailing edge to minimize drag and reduce resistance. In one ormore embodiments, the tapered leading edge may be configured to create asmooth entrance of fluid and the tapered tailing edge is configured tocreate a sharp exit for producing turbulent fluid flow upon exiting theflow diverter.

In one or more embodiments, the plurality of vanes may be configured toextend straight outwardly from the central axis of the lumen 40 to theside wall 30. In yet another embodiment, the plurality of vanes extendoutwardly from the central axis of the lumen in a curved configuration.In one or more embodiments, at least one edge of the plurality of vaneshas a ramped angled surface to create a greater angle of incidence.

The flow expansion channel and flow diverter of the present inventionmay have a variety of cross sectional geometries including, but notlimited to, a cross, rectangle, star, triangle, oval, spiral, twistingor helical formation.

The present invention is also directed to a luer connection device 10including a housing 20 having a side wall 30 with an inside surfacedefining a lumen 40, a proximal end 50 and a distal end 60 including adistal wall with an elongate male luer tip 70 extending in a distaldirection therefrom having a passageway therethrough providing fluidcommunication between the proximal end 50 and the distal end 60; and aflow expansion channel 90 being disposed in the lumen 40 taperingoutward from the wall of tubular housing 20 and partially extendingalong a longitudinal axis from the tip opening toward the base openingfor increasing mixing and flow through a circumferential dead space inthe fluid path distal to the male luer tip. The flow expanding channelsincrease mixing and flow through the “dead” space, thereby significantlyimproving the removal of the blood, medicine and/or other fluids andprovide superior flushing.

In one or more embodiments, the proximal end 50 is integrally connectedto a vascular access device. The vascular access device may be asyringe, extension set, intravenous set, stop cock, tubing, highpressure extension tubing, or needleless access device. In one or moreembodiments, the syringe is a pre-filled flush syringe. In yet anotherembodiment, the luer connection device 10 of claim is removablyconnected to a vascular access device.

In one or more embodiments, the flow expansion channel is configured toextend in a straight taper outwardly from the central axis of the lumen.In yet another embodiment of the present invention, the flow expansionchannel may be configured to extend in a rotational taper outwardly fromthe central axis of the lumen. In another embodiment, the flow expansionchannel may be is configured to scallop outwardly from the central axisof the lumen.

In one or more embodiments, the flow expansion channel is located at thedistal end and projects axially in a proximal direction towards theproximal end.

In one or more embodiments, the luer connection device 10 also includesa flow diverter 80 disposed in the lumen at or near the distal end ofthe male luer tip 70 to direct the fluid flow to the periphery of aconnecting female luer space upon application of force in the distaldirection. In one or more embodiments, the flow diverter 80 extendsbeyond the distal end of the housing 20. In one or more embodiments, theflow diverter 80 may be connected to the flow expansion channel 90. Inone or more embodiments, the flow expansion channel 90 may be locatedupstream from the flow diverter 80.

In one or more embodiments, the flow diverter 80 directs fluid flow intothe flow expansion channel 90. In another embodiment, the flow expansionchannel 90 directs fluid flow into the flow diverter 80. In one or moreembodiments, the flow diverter may merge into flow expansion channels.

It is envisioned that numerous combinations of flow expansion channelsand central flow diverters are possible including, but not limited to, astraight or rotational flow expanding channels on the inner diameter ofthe male luer space. Straight or rotational central flow divertershaving one or more flow channels are also within the scope of thepresent invention. In one embodiment of the present invention, the maleluer tip may include a rotational flow expanding channels and a central,circulating flow diverter. As shown in FIG. 5 , in some embodiments, theentirety of the central flow diverter 80 is located upstream from theflow expansion channel 90 such that a distal end 82 of the central flowdiverter 80 is upstream from a proximal end 92 of the flow expansionchannel 90, wherein the flow expansion channel 90 is a separate elementfrom the central flow diverter 80.

FIG. 2 illustrates an exemplary luer connection device 10 having a flowexpansion channel 90 and flow diverter 80 that are both configured toextend in a straight taper towards the central axis of the lumen. Inanother embodiment, the flow expansion channel is configured to extendin a rotational taper towards the central axis of the lumen and flowdiverter 80 is configured to extend in a straight taper towards thecentral axis of the lumen. FIG. 5 illustrates an exemplary luerconnection device 10 having a male luer tip with a rotational flowexpansion channels and central flow diverters.

In yet another embodiment, the flow diverter is configured to extend ina rotational taper towards the central axis of the lumen and flowexpansion channel is configured to extend in a straight taper towardsthe central axis of the lumen.

Blood-derived debris in the deadspace is dislodged by diverting thefluid flow to the periphery of the connecting female luer space during aflush procedure to increase mixing and turbulence in the dead spacecreated by a male luer tip.

FIG. 3 illustrates an exemplary luer connection device 10 havingstraight non-rotational flow expansion channels and rotational flowdiverter.

FIG. 4 illustrates an exemplary luer connection device 10 havingstraight non-rotational flow expanding channels.

FIG. 5 illustrates an exemplary luer connection device 10 havingrotational flow expansion channels.

FIG. 6 shows a front view of the flow diverter located at the distal end60. FIG. 6 illustrates an exemplary luer connection device 10 having astraight non-rotational flow expansion channels and rotational diverterhaving ramped angled edges.

FIG. 7 illustrates an exemplary luer connection device 10 having a flowdiverter and straight flow expansion channels. FIG. 8 shows a side viewof luer connection device, illustrating how flow expansion channels 90protrude/twist as it courses evenly and smoothly from proximal end 50 todistal end 60.

The purpose of the flow expanding channels is to increase mixing andflow through the “dead” space, thereby significantly improving theremoval of the blood, medicine and/or other fluids and provide superiorflushing.

The flow diverter can direct flow into deadspace located between a maleand female luer connection so as to minimize the trapping of bloodwithin the passageway.

Flow diverter 80 is provided within the male luer tip to force the fluidflow to the periphery of the connecting female luer space during a flushprocedure to increase mixing and turbulence in the dead space created bya male luer tip between a male and female luer connection. This enhancedflushing results in a reduction in the risk of infection due to residualblood in the catheter system. The flow diverter 80 is integrally formedwithin male luer tip.

The tip has a flow expanding channel and flow diverter. The flow offlushing fluid then circulates radially outward through the flowdiverter to the outer periphery of the tip into the deadspace.

The flush enhancing luer connection device of the present invention,with either flow expanding channels or a flow diverter, or a combinationof the two, provides a significant improvement to the standard flushdevices and procedures. This is accomplished by diverting the fluid flowto the periphery of the connecting female luer space during a flushprocedure to increase mixing and turbulence in the dead space created bya male luer tip. This enhanced flushing results in a reduction in therisk of infection due to residual blood in the catheter system.

The dimensions of the luer connection device of the present inventioncan be made to comply with applicable standards and/or regulations, suchas ISO standard 594.

Reference throughout this specification to “one embodiment,” “certainembodiments,” “one or more embodiments” or “an embodiment” means that aparticular feature, structure, material, or characteristic described inconnection with the embodiment is included in at least one embodiment ofthe invention. Thus, the appearances of the phrases such as “in one ormore embodiments,” “in certain embodiments,” “in one embodiment” or “inan embodiment” in various places throughout this specification are notnecessarily referring to the same embodiment of the invention.Furthermore, the particular features, structures, materials, orcharacteristics may be combined in any suitable manner in one or moreembodiments.

Although the invention herein has been described with reference toparticular embodiments, it is to be understood that these embodimentsare merely illustrative of the principles and applications of thepresent invention. It will be apparent to those skilled in the art thatvarious modifications and variations can be made to the method andapparatus of the present invention without departing from the spirit andscope of the invention. Thus, it is intended that the present inventioninclude modifications and variations that are within the scope of theappended claims and their equivalents.

What is claimed is:
 1. A luer connection device comprising: a housingincluding a side wall having an inside surface defining a lumen with acentral axis, a proximal end, and a distal end, the lumen extending fromthe proximal end through to the distal end, the lumen including a maleluer tip within the lumen having a passageway there through providingfluid communication between the proximal end and the distal end; and aflow expansion channel disposed in the lumen tapering outward from thewall of tubular housing and partially extending along a longitudinalaxis for increasing mixing and flow through a circumferential dead spacein a fluid path distal to the male luer tip, wherein the vascular accessdevice further comprises a flow diverter disposed in the lumen at ornear the distal end of the male luer tip to direct the fluid flow to theperiphery of a connecting female luer space upon application of forcetoward the distal direction, and wherein the flow expansion channel orflow diverter is configured to extend in a straight taper towards thecentral axis of the lumen; and wherein the flow expansion channel isconnected to the central flow diverter to allow fluid communicationbetween the flow expansion channel and the central flow diverter.
 2. Avascular access device incorporating the luer connection device ofclaim
 1. 3. The vascular access device of claim 2, wherein the vascularaccess device is a syringe, extension set, intravenous set, stop cock,tubing, high pressure extension tubing, or needleless access device. 4.The luer connection device of claim 1, wherein the proximal end isremovably connected to a vascular access device.
 5. The luer connectiondevice of claim 4, wherein the vascular access device is a syringe,extension set, intravenous set, stop cock, tubing, high pressureextension tubing, or needleless connector.
 6. The vascular access deviceof claim 3, wherein the syringe is a pre-filled flush syringe.
 7. Theluer connection device of claim 1, wherein the flow expansion channel isconfigured to extend in a straight taper outwardly from the central axisof the lumen.
 8. The luer connection device of claim 1, wherein the flowexpansion channel is configured to extend in a rotational taperoutwardly from the central axis of the lumen.
 9. The luer connectiondevice of claim 1, wherein the flow expansion channel is configured toscallop outwardly from the central axis of the lumen.
 10. The luerconnection device of claim 1, wherein the flow expansion channel islocated at the distal end and projects axially in a proximal directiontowards the proximal end.
 11. The luer connection device of claim 1,wherein the flow diverter is connected to the flow expansion channel.12. The luer connection device of claim 1, wherein the flow expansionchannel is located upstream from the flow diverter.
 13. The luerconnection device of claim 1, wherein the flow diverter directs fluidflow into the flow expansion channel.
 14. The luer connection device ofclaim 1, wherein the flow expansion channel directs fluid flow into theflow diverter.
 15. The luer connection device of claim 1, wherein theflow expansion channel is configured to extend in a rotational tapertowards the central axis of the lumen and flow diverter is configured toextend in a straight taper towards the central axis of the lumen. 16.The luer connection device of claim 1, wherein the flow diverter isconfigured to extend in a rotational taper towards the central axis ofthe lumen and flow expansion channel is configured to extend in astraight taper towards the central axis of the lumen.